Trial reportBMC musculoskeletal disorders2013
Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study.
Trial report in BMC musculoskeletal disorders, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Multi-center Parallel Group Phase IV Study to Evaluate the Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain
Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Clinical Practice Guidelines for Topical NSAIDs in the Treatment of Sports Injuries.Journal of evidence-based medicine · 2025Guideline
- Topical NSAIDs for acute musculoskeletal pain in adults.The Cochrane database of systematic reviews · 2015Pooled it
- Randomized, double-blind, noninferiority study of diclofenac diethylamine 2.32% gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily in patients with acute ankle sprain.BMC musculoskeletal disorders · 2022Trial
- Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial.The Journal of international medical research · 2017Trial
- Topical Pain Management: An Updated Review of Current Evidence and Emerging Strategies.Journal of clinical medicine · 2026Review
- 7. Cervical facet pain: Degenerative alterations and whiplash-associated disorder.Pain practice : the official journal of World Institute of Pain · 2025Review
- Hypothesizing the Oleic Acid-Mediated Enhanced and Sustained Transdermal Codelivery of Pregabalin and Diclofenac Adhesive Nanogel: A Proof of Concept.Current molecular medicine · 2024Article
- A pre-market interventional, single-arm clinical investigation of a new topical lotion based on hyaluronic acid and peptides, EGYFILBMC musculoskeletal disorders · 2023Article
- Pharmacotherapy for Spine-Related Pain in Older Adults.Drugs & aging · 2022Review
- Author's Response to: 'Letter to the Editor Regarding Efficacy and Safety of Diclofenac and Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study'.Pain and therapy · 2020Article
- Penetration of topical diclofenac into synovial tissue and fluid of osteoarthritic knees: a multicenter, randomized, placebo-controlled, pharmacokinetic study.Therapeutic advances in musculoskeletal disease · 2020Article
- Article
- National clinical guidelines for non-surgical treatment of patients with recent onset neck pain or cervical radiculopathy.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNeck pain (NP) is a common musculoskeletal disorder in primary care that frequently causes discomfort. Non-steroidal anti-inflammatory drugs (NSAIDs) may be used to reduce neck pain and associated inflammation and facilitate earlier recovery. Topical diclofenac diethylamine (DDEA) 1.16% gel is clinically proven to be effective and well tolerated in acute and chronic musculoskeletal conditions, but until now no clinical data existed for its use in acute NP. The aim of this study was to assess the efficacy and safety of DDEA 1.16% gel compared with placebo gel in acute NP.
methodsIn a randomized, double-blind, placebo-controlled study, patients with acute NP (n = 72) were treated with DDEA 1.16% gel (2 g, 4x/day, for 5 days) or placebo. Efficacy assessments included pain-on-movement (POM), pain-at-rest (PAR), functional neck disability index (NDI) and response to treatment (decrease in POM by 50% after 48 h). Adverse events (AEs) were recorded throughout the study.
resultsThe primary outcome, POM at 48 h, was statistically significantly lower with DDEA gel (19.5 mm) vs. placebo (56.9 mm) (p < 0.0001), representing a clinically relevant decrease from baseline (75% vs. 23%, respectively). All POM scores were significantly lower with DDEA gel vs. placebo from 1 h, as were PAR and NDI scores from first assessment (24 h) onwards (all p < 0.0001). Response to treatment was significantly higher with DDEA gel (94.4%) vs. placebo (8.3%) (p < 0.0001). There were no AEs with DDEA gel.
conclusionsDDEA 1.16% gel, which is available over-the-counter, was effective and well tolerated in the treatment of acute neck pain. The tools used to assess efficacy suggest that it quickly reduced neck pain and improved neck function. However, questions remain regarding the comparability and validity of such tools. Further studies will help ascertain whether DDEA 1.16% gel offers an alternative treatment option in this common, often debilitating condition.
trial registrationClinicalTrials.gov identifier: NCT01335724.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.